Policies & Procedures

Research Standard Operating Procedures

An SOP is a written process and a way for the clinical site to perform a task the same way each time it is completed. It includes “detailed, written instructions to achieve uniformity of the performance of a specific function.” (ICH GCP 1.55)

SOPs are used to:

Identify the responsible person for each task

Describe what is to be completed

Train staff

Monitor site performance

What are the benefits of using SOPs?

Ensure that sites follow federal regulations, International Conference on Harmonization Good Clinical Practice guidelines, and UH institutional policies to protect the rights and welfare of human study participants.

University Hospitals Cleveland Medical Center’s Institutional Review Board (IRB) reviews its policies for adherence to current FDA and Institutional regulations every three years to ensure compliance. This policy review process is conducted to ensure appropriate maintenance of our AAHRPP accreditation as part of UH Cleveland Medical Center’s commitment to the highest Human Research Protection standards. The FDA regulations pertinent to IRBs include 21 CFR 50, Part 56, Part 312, and Part 812.

Research policies in the UH System Policy Manual apply to all workforce members throughout UH who are engaged in research in any capacity. Much of the training and education provided by the Clinical Research Center reference these policies to ensure that compliance standards set by University Hospitals are met.

OHRP makes available the full text of the HHS regulations for the protection of human subjects in research (45 CFR 46), the Common Rule (45 CFR 46 Subpart A), and FDA human subject protection regulations.

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